As is well known, the cutting and sewing of tissue are two important aspects of surgery. With respect to the sewing of tissue, a vast array of needle and suturing devices are available. These devices, however, have been basically unchanged since the introduction of the modern needle holder and curved needle.
There are basic stitch movements involved in most surgical sewing procedures. These basic movements are as follows: gripping the shank portion of a needle with a needle holder, manipulating the needle holder to push the pointed end portion of the needle at least partly through the tissue, disengaging the shank portion of the needle from the needle holder, gripping the pointed end portion of the needle with a suitable gripping means, pulling the needle and the suture completely through the tissue, supporting the needle with a suitable means (e.g., fingers, forceps, etc.), regripping the shank portion of the needle with the needle holder and repeating the procedure as necessary.
Although these steps have been used for many decades, there are problems associated therewith. For example, due to the inherent sharpness of the pointed end portion of the needle, extreme care has to be used when gripping the needle as it is passing through the tissue. Specifically, if the gripping means is the thumb and forefinger of a medical practitioner, the needle may puncture these appendages. This is of major concern to both the practitioner and the patient especially with the growing awareness of the means by which the AIDS virus can be transmitted. Notwithstanding the potential problems associated with the implementation of this gripping procedure, many practitioners still use it.
In an attempt to remedy this problem, some medical practitioners use a forceps-type apparatus to grip the pointed end portion of the needle. Although this approach keeps the practitioner's fingers from coming in direct contact with the needle's point, there are still problems associated therewith. For example, the use of a forceps has been known to dull and/or etch barb-like protrusions on the pointed end portion of a needle. This complicates the suturing process.
Over the years, there have been other attempts to improve the manner by which a needle's point is gripped as it passes through a patient's tissue. One of these attempts is disclosed in U.S. Pat. No. 3,511,242 (henceforth the '242 patent). Specifically the '242 patent discloses a surgical finger cot having a hollow flexible body adapted for receiving a finger therein. On at least one side of this flexible body, there is a relatively stiff "ear" which protrudes tangentially therefrom. This protruding ear, which has a well-defined terminal edge, is designed to provide a back-up for the needle's point as it passes through the patient's tissue.
Although the purpose of the ears disclosed in the '242 patent is to protect a medical practitioner's finger from the needle's point, the practitioner's fingers may still be punctured if extreme care is not used. Specifically, the surface area of the ears is relatively small when compared to the surface area of the unprotected finger in the finger cot. Therefore, the margin of error allowed, when guessing exactly where the needle's point will emerge from the patient's tissue is also relatively small. Accordingly, if the practitioner makes a slight miscalculation as to the location of the needle's point while it is under the tissue being sewn, there is a high probability that the practitioner's finger will be punctured.
Another problem associated with the needle gripping means disclosed in the '242 patent pertains to the fact that it is physically attached to the practitioner's finger via the finger cot. This phenomena limits the implementation of such a gripping means since it can be used only where the practitioner's finger can reach. Such a limitation is significant since it prohibits the employment of this gripping means with certain types of surgical procedures (e.g., endoscopic surgical procedures).
U.S. Pat. No. 3,878,848 (henceforth the '848 patent) discloses another attempt to improve the manner in which a needle's point is gripped as it passes through a patient's tissue. In the '848 patent, a surgical needle capturing device is disclosed which includes a "body member" having sufficient stiffness to be penetrated by a needle's point as it passes through a patient's tissue. This body member serves a similar purpose as the "ears" which were disclosed in the '242 patent.
One major differences between the approach disclosed in the '848 patent and that disclosed in the '242 patent is that, in the approach disclosed in the '848 patent, the body member is secured to a "handle member" which is, itself, attached to a "manipulating element". While this difference affords the approach disclosed in the '848 patent a greater range of use, there are still significant limitations associated therewith.
For example, in the device disclosed in the '848 patent, the body member is formed around a bifurcation or U-shaped extension defined at one end of the handle member. This is the only means by which these two components are attached to one another. Accordingly, a medical practitioner cannot be certain if, and/or when, the two will separate from one another.
The possibility of the two separating from one another is of great concern to the medical profession. For example, if the two separate while the device is being used to capture a needle being employed in an endoscopic surgical procedure, the obvious consequences can be catastrophic and even fatal.
In the past decade, the number and frequency of endoscopic surgical procedures has increased significantly. As surgical instruments become more refined, those in the medical profession expect these numbers to continue growing. Also in the past decade, the concern for protecting medical practitioners from being infected by, and/or transmitting, the AIDS virus has increased significantly.
Notwithstanding the events which have taken place in the past decade, the means employed by medical practitioners to grip the pointed end portion of a needle still remain unchanged. Therefore, there is an immediate need for an improved method for gripping the pointed end portion of a surgical needle as it passes through a patient's tissue.